• BioDelivery Sciences International Inc., of Morrisville, N.C., received its initial $30 million nonrefundable milestone payment from Solna, Sweden-based Meda AB, which earlier this month exclusively licensed commercialization rights to BDSI's BEMA Fentanyl in the U.S., Canada and Mexico. BDSI said the receipt of that milestone will help the firm generate positive cash flow in 2007. The company anticipates a potential commercial launch of BEMA Fentanyl, a dissolvable polymer delivery system formulated with the opioid narcotic, in 2008. (See BioWorld Today, Sept. 6, 2007.)

• Cephalon Inc., of Frazer, Pa., said it communicated with health care professionals to clarify and reinforce the appropriate patient selection, dosing and administration for the pain drug Fentora (fentanyl). The letter, issued in collaboration with the FDA, came in response to deaths in patients who were not appropriate candidates for the buccal-tablet drug - events that apparently took place as a result of improper use in patients who were not already taking opioids around the clock, improper dosing of the medication and/or improper substitution of Fentora for other fentanyl-based medications.

• Exelixis Inc., of South San Francisco, said it submitted a comprehensive data report relating to XL880 to London-based GlaxoSmithKline plc upon GSK's request to initiate review of the compound before it reaches proof of concept, as defined under the companies' collaboration. GSK now has 90 days to review the data package to determine whether it will select XL880, a MET inhibitor for treating cancer, for further development and commercialization. Under the 2002 agreement, GSK holds the option to elect up to three compounds for further development from Exelixis' pipeline - XL784, XL880, XL184, XL820, XL999, XL844, XL228, XL281 and XL418. In July, the pharma firm passed on the cancer compound XL647, though Exelixis has said it will move that program into pivotal trials on its own, following receipt of promising proof-of-concept data. (See BioWorld Today, July 27, 2007.)

• Pro-Pharmaceuticals Inc., of Newton, Mass., received notice from the American Stock Exchange staff that it has accepted the company's plan of compliance and granted an extension until Oct. 13, 2008, to regain compliance with continued listing standards. Pro-Pharmaceuticals received notice June 22 from Amex indicating that it was below standards due to losses in two of its last three years, with stockholders' equity below $2 million.

• Santarus Inc., of San Diego, filed a patent infringement lawsuit in the U.S. District Court of Delaware against Par Pharmaceutical Inc., of Woodcliff Lake, N.J., relating to patents listed in the Orange Book for Zegerid (omeprazole/sodium bicarbonate) capsules. The suit is in response to an abbreviated new drug application filed by Par for its generic version of Zegerid capsules prior to the July 2016 patent expiration date. Santarus commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving Par's ANDA for 30 months or until a court decision that is adverse to Santarus. The University of Missouri, licensor of the patents, is a co-plaintiff.

• The Medicines Co., of Parsippany, N.J., said the FDA accepted the company's new drug application for Cleviprex (clevidipine butyrate injectable emulsion) in acute hypertension. The NDA was based on results from six Phase III trials, in which the drug met all primary endpoints. An intravenous antihypertensive, Cleviprex is designed to be metabolized in the blood, rather than by the kidneys or liver, and does not accumulate in the body. If approved, the company anticipates making Cleviprex available to patients in mid-2008.

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